RecruitingNot ApplicableNCT07355842

Role of Slow Waves in the Progression of Neurodegeneration in Isolated REM Sleep Behavior Disorder


Sponsor

University of Zurich

Enrollment

80 participants

Start Date

Jan 15, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

This study tests whether enhancing deep sleep with gentle sounds at night can slow progression in people with iRBD or early Parkinson's disease. Participants wear a sensor headband and headphones for 18 months. Four assessments including mobility, memory, imaging (PET/MRI), lumbar puncture, and blood tests are assessed.


Eligibility

Plain Language Summary

Simplified for easier understanding

This study is investigating whether stimulating slow brain waves during sleep — using gentle sounds played through headphones — can slow the progression of neurodegeneration in people with a condition called isolated REM sleep behavior disorder (iRBD), where people physically act out their dreams. This condition often precedes Parkinson's disease, and researchers want to see if this sleep-based treatment can delay or prevent that transition. **You may be eligible if:** - You have been diagnosed with isolated REM sleep behavior disorder confirmed by a sleep study - You also have either reduced sense of smell and movement abnormalities, OR a recent Parkinson's diagnosis (within 2 years) - You are not currently on dopamine-based Parkinson's medication and don't expect to start during the study - You can hear the audio tones used in the treatment - You are able to apply the intervention at home, with or without a housemate's help - You speak German, French, or Italian **You may NOT be eligible if:** - You have significant sleep apnea (AHI > 15 per hour) unless treated with CPAP - You have restless legs syndrome, dementia, or severe depression - You have atypical Parkinson's syndrome - You are pregnant or planning to become pregnant - You regularly use sedatives, benzodiazepines, or have a substance use disorder - You have a hearing impairment that prevents you from hearing the tones Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICETosoo Axora

Phase Targeted Auditory Stimulation (PTAS) will be applied through integrated headphones with a portable EEG device when non-rapid-eye-movement (NREM) sleep is detected during the night.

DEVICETosoo Axora

Auditory stimuli will be delivered during the night through integrated headphones with a portable EEG device in a non-PTAS manner.


Locations(1)

University Hospital Zurich, Neurology Department

Zurich, Canton of Zurich, Switzerland

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NCT07355842


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